Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00091598




Registration number
NCT00091598
Ethics application status
Date submitted
10/09/2004
Date registered
14/09/2004
Date last updated
8/03/2010

Titles & IDs
Public title
ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
Scientific title
ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
ARIES
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Ambrisentan

Treatment: Drugs: Ambrisentan
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline at Week 12 of six minute walk distance
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change from baseline at Week 12 of:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Borg Dsypnea Index
Timepoint [2] 0 0
Secondary outcome [3] 0 0
WHO Functional Classification
Timepoint [3] 0 0
Secondary outcome [4] 0 0
SF-36
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Time to Clinical Worsening
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- Diagnosis of idiopathic PAH (formally known as PPH), or PAH associated with collagen
vascular disease, anorexigen use, or HIV infection;

- Historical cardiac catheterization with the following hemodynamic criteria:

Mean pulmonary artery pressure greater than or equal to 25 mmHg; Pulmonary vascular
resistance greater than 3 mmHg/L/min; Pulmonary capillary wedge pressure or left
ventricular end diastolic pressure less than 15 mmHg;

- 6-minute walk distance of at least 150 meters, but no more than 450 meters;

- Total lung capacity greater than or equal to 70% and FEV1 greater than or equal to 65%
of predicted normal;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Portopulmonary hypertension;

- Subjects with PAH due to or associated with coronary artery disease, left heart
disease, interstitial lung disease, chronic obstructive pulmonary disease,
veno-occlusive disease, chronic thromboembolic disease, or sleep apnea;

- Bosentan (Tracleer®), sildenafil (Viagra®), or chronic prostanoid therapy within 4
weeks of screening;

- Serum ALT or AST lab value that is greater than 1.5 times the upper limit of normal;

- Contraindication to treatment with an endothelin receptor antagonist;

- Subject with cardiovascular, hepatic, renal, hematologic, gastrointestinal,
immunologic, endocrine, metabolic, or central nervous system disease that may
adversely affect the safety of the subject;

- Participation in a clinical study involving another investigational drug within 4
weeks of screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to determine the effect of ambrisentan on exercise capacity in
subjects with PAH.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00091598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lewis J. Rubin, MD
Address 0 0
University of California San Diego, San Diego School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00091598